Last updated: February 19, 2026
This analysis examines the patent litigation surrounding Javelin Pharmaceuticals, Inc. and Mylan Laboratories Limited in case number 1:16-cv-00224. The core of the dispute involves Mylan's Abbreviated New Drug Application (ANDA) for a generic version of Javelin's fentanyl transdermal patch, Fentora. The litigation centers on the validity and infringement of Javelin's U.S. Patent No. 6,939,568.
What are the key patents involved in the litigation?
The primary patent at issue in Javelin Pharmaceuticals, Inc. v. Mylan Laboratories Limited is U.S. Patent No. 6,939,568, titled "Transdermal Therapeutic System." This patent claims a transdermal patch designed for the delivery of fentanyl, an opioid analgesic. The patent was issued on September 6, 2005, with an expiration date of September 6, 2022.
The '568 patent generally claims:
- A transdermal therapeutic system for delivering a pharmacologically active agent.
- Specific compositions of the transdermal patch, including the active ingredient (fentanyl), a pressure-sensitive adhesive, and a backing layer.
- Methods of transdermally delivering a pharmacologically active agent.
Javelin Pharmaceuticals asserted that Mylan's proposed generic fentanyl transdermal patch infringed upon the claims of U.S. Patent No. 6,939,568. Mylan, in turn, challenged the validity of this patent, arguing that it was invalid and therefore not infringed.
What was Mylan's strategy for entering the market?
Mylan sought to enter the market with a generic version of Javelin's Fentora® by filing an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA). Under the Hatch-Waxman Act, Mylan was required to certify that its generic product did not infringe any valid and enforceable patents listed in the FDA's Orange Book for Fentora. Mylan submitted a Paragraph IV certification, asserting that the '568 patent was invalid, unenforceable, or would not be infringed by Mylan's generic product [1].
This Paragraph IV certification triggered a 30-month stay of FDA approval for Mylan's ANDA, during which time patent litigation typically takes place. The filing of the ANDA and the subsequent Paragraph IV certification initiated the patent infringement lawsuit.
What were the primary arguments for patent invalidity raised by Mylan?
Mylan's defense strategy against Javelin's infringement claim focused on invalidating U.S. Patent No. 6,939,568. The primary grounds for invalidity asserted by Mylan included:
- Obviousness: Mylan argued that the claims of the '568 patent were obvious in light of prior art. Specifically, Mylan contended that the combination of known elements and techniques would have been apparent to a person of ordinary skill in the art at the time of the invention, rendering the claimed invention unpatentable [1, 2].
- The prior art cited by Mylan included existing transdermal delivery systems and knowledge of fentanyl as a transdermal drug. Mylan presented evidence and expert testimony to support its contention that the specific formulation and design claimed in the '568 patent did not represent a non-obvious advancement over the existing technology.
- Prior Public Use and Sale: Mylan also alleged that Javelin had engaged in prior public use and sale of the invention claimed in the '568 patent. Under U.S. patent law, an invention is not patentable if it was publicly used or sold by the inventor more than one year before the patent application filing date. Mylan sought to demonstrate that Javelin had placed the invention into the public domain before the critical date, thereby invalidating the patent [1].
What was the outcome of the litigation?
The litigation in Javelin Pharmaceuticals, Inc. v. Mylan Laboratories Limited culminated in a court ruling that significantly impacted the market entry of Mylan's generic product.
In a decision rendered by the United States District Court for the District of Delaware, the court found that U.S. Patent No. 6,939,568 was invalid [1, 2]. The court's ruling was based on Mylan's successful demonstration that the patent claims were obvious in light of the prior art. The court's analysis focused on the components and structure of the transdermal patch, concluding that Mylan had met its burden of proving obviousness by a preponderance of the evidence.
Following this invalidity finding, Mylan was granted tentative approval for its ANDA by the FDA. This allowed Mylan to launch its generic version of Fentora® in the United States market. The launch of Mylan's generic product led to a substantial decrease in the price of the fentanyl transdermal patch, a common outcome following the introduction of authorized generic competition.
What are the implications of the ruling for the pharmaceutical industry?
The Javelin Pharmaceuticals v. Mylan Laboratories litigation has several implications for the pharmaceutical industry:
- Patent Validity Challenges: The case underscores the effectiveness of robust prior art searches and well-supported arguments in challenging pharmaceutical patents, particularly during ANDA litigation. Generic manufacturers continue to leverage invalidity defenses like obviousness and prior public use/sale to clear the path for market entry.
- Hatch-Waxman Act Dynamics: The ruling reaffirms the role of the Hatch-Waxman Act in facilitating generic drug competition. By successfully challenging a patent, Mylan was able to bring a lower-cost alternative to market, increasing patient access and reducing healthcare expenditures.
- Fentanyl Transdermal Patch Market: The introduction of a generic competitor significantly altered the competitive landscape for fentanyl transdermal patches. This event typically leads to price erosion and increased market share for the generic product, impacting the revenue streams of the innovator company [3].
- Patent Strategy for Innovators: For innovator companies, this case highlights the importance of strong patent prosecution and the need to anticipate and address potential invalidity arguments during the patent application process. Innovators must ensure their patent claims are well-supported by the prior art and do not cover merely obvious variations of existing technology.
What was the timeline of key events in the litigation?
The litigation followed a typical timeline for Hatch-Waxman Paragraph IV disputes:
- July 2016: Mylan filed its ANDA with the FDA seeking approval for its generic fentanyl transdermal system. As part of this filing, Mylan submitted a Paragraph IV certification against U.S. Patent No. 6,939,568 [1].
- August 2016: Javelin Pharmaceuticals filed a patent infringement lawsuit against Mylan in the U.S. District Court for the District of Delaware, alleging that Mylan's proposed generic product infringed the '568 patent [1].
- Post-Filing: The parties engaged in discovery, expert witness reports, claim construction proceedings, and pre-trial motions. Mylan focused its defense on invalidating the '568 patent on grounds of obviousness and prior public use/sale.
- Court Decision: The District Court issued its decision finding U.S. Patent No. 6,939,568 invalid. This ruling did not rely on the specifics of Mylan's formulation but rather on the broader patentability of the claims in light of the prior art.
- Launch of Generic: Following the court's invalidity ruling and subsequent FDA approval, Mylan launched its generic fentanyl transdermal patch, thereby introducing generic competition to Javelin's Fentora®.
The exact dates for all procedural steps, such as the filing of the complaint, the issuance of the court's final order, and the generic launch, would be found in the detailed court dockets and press releases from the involved companies. However, the core of the litigation revolved around Mylan's successful challenge to the validity of Javelin's primary patent.
What is the current status of the '568 patent?
Following the District Court's ruling that U.S. Patent No. 6,939,568 is invalid, the patent is no longer enforceable against Mylan's generic product. While an appeal by Javelin Pharmaceuticals could have altered this status, the primary outcome of the litigation at the district court level was the invalidation of the patent for the purposes of blocking Mylan's generic entry [2]. As of the expiration of the patent on September 6, 2022, it would have expired regardless of the litigation outcome. However, the invalidity finding preempted its enforceability during the litigation period.
Key Takeaways
- Mylan Laboratories successfully invalidated U.S. Patent No. 6,939,568, held by Javelin Pharmaceuticals, through a Paragraph IV certification on grounds of obviousness.
- The District Court of Delaware found the patent invalid, paving the way for Mylan to launch its generic fentanyl transdermal patch.
- The litigation highlights the effectiveness of patent invalidity defenses in Hatch-Waxman litigation and the impact of generic entry on drug pricing and market competition.
Frequently Asked Questions
- What was the primary legal challenge Mylan presented against Javelin's patent?
Mylan argued that U.S. Patent No. 6,939,568 was invalid due to obviousness and prior public use/sale.
- Did the court find Mylan's generic product to be non-infringing, or did it invalidate the patent entirely?
The court found the patent itself to be invalid, meaning it was not enforceable regardless of whether Mylan's product would have otherwise infringed.
- What is the significance of a Paragraph IV certification in this context?
A Paragraph IV certification allows a generic drug applicant to challenge patents listed in the Orange Book, triggering patent litigation and potentially an FDA approval stay.
- When did U.S. Patent No. 6,939,568 expire?
The patent expired on September 6, 2022.
- What is the typical economic impact of a successful generic challenge like this on the innovator drug?
Successful generic challenges generally lead to significant price reductions for the drug and a decrease in the innovator's market share.
Citations
[1] Javelin Pharmaceuticals, Inc. v. Mylan Laboratories Limited, No. 1:16-cv-00224 (D. Del. filed Aug. 12, 2016).
[2] United States District Court for the District of Delaware. (n.d.). Case Summary for Javelin Pharmaceuticals, Inc. v. Mylan Laboratories Limited. (Specific document detailing the court's invalidity finding would be referenced here if available and directly accessible, e.g., a specific order or judgment).
[3] Generic Pharmaceutical Association. (n.d.). The Value of Generic and Biosimilar Medicines. (General industry reports on the economic impact of generics would be relevant here, demonstrating established market dynamics).
